Drugs

Ex-Pharmakon CEO Convicted on FDA Fraud, Adulteration

Former Pharmakon Pharmaceuticals CEO Paul J. Elmer has been convicted of conspiracy to defraud FDA and nine counts of adulterating drugs at the company’s Noblesville, IN drug compounding facility. The government charged that from 2013 to 2016, Elmer and Caprice R. Bearden, Pharmakon’s former compliance director, caused Pharmakon to distribute about 70 lots of over- and under-potent drugs to military and civilian hospitals throughout the country, according to the Department of Justice (DoJ). Bearden pleaded guilty to all the charges in the original indictment on 11/21/2017. Her sentencing date has not been scheduled.

According to the government, Pharmakon routinely shipped compounded drugs at Elmer’s direction to customers without obtaining laboratory test results that verified the drugs were the strength they were supposed to be. “Furthermore, evidence showed that, despite receiving test results showing potency failures, Elmer did not recall the drugs, notify the customer, notify the FDA of the potency failures, or conduct any root cause investigation to determine the cause of the failure,” DoJ says.

Elmer faces up to five years in prison and a fine of up to $250,000 for defrauding FDA. He also could get an additional year in prison and a $100,000 fine for each adulteration charge. Elmer’s sentencing date has also not been scheduled.

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome